FDA.reportPublic FDA data

Fenofibrate

Product NDC
33342-347
11-digit product format
333420347
Labeler code
33342
Product ID
33342-347_a504c42a-b629-4a21-a716-084962266b48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibrate
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA210379
Marketing category
ANDA
Marketing start
2026-01-21
Substance
FENOFIBRATE
Active strength
54 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210379-001FENOFIBRATEFENOFIBRATE54MGTABLET / ORALAB2026-01-21
A210379-002FENOFIBRATEFENOFIBRATE160MGTABLET / ORALAB2026-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A210379-001AB
A210379-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210379-001FENOFIBRATE54MGTABLET / ORALAB2026-01-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210379-002FENOFIBRATE160MGTABLET / ORALAB2026-01-21011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210379-001FENOFIBRATE54MGTABLET / ORALAB2026-01-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210379-002FENOFIBRATE160MGTABLET / ORALAB2026-01-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210379-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210379-002AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210379-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210379-002AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Fenofibrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRATE54 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U202363UOSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349287Internal RxNorm lookup
351133Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a504c42a-b629-4a21-a716-084962266b48Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
193bb7da-5c03-8f95-9048-23ef403846b0Product name320250616
fa35fb9a-7146-716b-13c8-bc1f60030232Product name920250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07Product name820231212
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708
36a239c8-03fb-0083-81af-6c1afb195671Product name120140508
a0296d70-ca85-018c-84e8-cf3f630976b7Product name120140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-347-10Fenofibrate90 in 1 CONTAINERTABLET901
33342-347-12Fenofibrate10 in 1 CARTONTABLET101
33342-347-12Fenofibrate10 in 1 BLISTER PACKTABLET101
33342-347-47Fenofibrate9 in 1 CARTONTABLET91
33342-347-47Fenofibrate14 in 1 BLISTER PACKTABLET141

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FenofibrateFENOFIBRATEMacleods Pharmaceuticals Limiteda504c42a-b629-4a21-a716-084962266b482026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210379
application number: ANDA210379
ndc (product): 33342-347

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349287fenofibrate 160 MG Oral TabletPSNa504c42a-b629-4a21-a716-084962266b481
351133fenofibrate 54 MG Oral TabletPSNa504c42a-b629-4a21-a716-084962266b481
349287fenofibrate 160 MG Oral TabletSCDa504c42a-b629-4a21-a716-084962266b481
351133fenofibrate 54 MG Oral TabletSCDa504c42a-b629-4a21-a716-084962266b481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-347-103334203471090 TABLET in 1 CONTAINER (33342-347-10) 90 tablet2026-01-21NoNoCurrent
33342-347-123334203471210 BLISTER PACK in 1 CARTON (33342-347-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2026-01-21NoNoCurrent
33342-347-47333420347479 BLISTER PACK in 1 CARTON (33342-347-47) / 14 TABLET in 1 BLISTER PACK9 blister pack2026-01-21NoNoCurrent